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U.S. Needs FDA Food Safety Czar Now, Separate Agency Later, Group Says

This article was originally published in The Tan Sheet

Executive Summary

FDA should appoint an executive with oversight for all food safety operations in the near term, and the government should establish a separate food agency outside FDA in the long term, a non-profit group says

FDA should appoint an executive with oversight for all food safety operations in the near term, and the government should establish a separate food agency outside FDA in the long term, a non-profit group says.

Trust for America's Health, working with the Robert Wood Johnson Foundation, which helps fund the group, on March 25 released "a road map for the first steps toward revamping" the food safety system.

The report recommends lobbying Congress to move FDA divisions into a separate Department of Health and Human Services agency for food safety. TFAH and RWJF push for "strategically aligning and elevating the food safety functions currently housed at FDA and better coordinating regulation policies and practices" with the Centers for Disease Control and with state and local agencies to prevent and respond to outbreaks.

The report arrives as the administration and lawmakers are considering a number of scenarios for overhauling the country's food safety system. President Obama recently announced a Food Safety Working Group to advise him on improving coordination and collaboration across federal agencies. That group also will recommend legislative and regulatory changes to improve food safety.

In a same-day media briefing, TFAH Executive Director Jeff Levi said the salmonella outbreak linked to the Peanut Corporation of America that led to hundreds of cases of illness, more than 3,500 product recalls and possibly nine deaths shows a change is needed urgently (1 (Also see "Congress Stresses Food Safety Responsibility For All Links In Supply Chain" - Pink Sheet, 23 Mar, 2009.), p. 5).

The salmonella contamination is "the tipping point" that "created the political will" for Congress to move quickly, he said.

FDA appointed its first food safety chief, David Acheson, in May 2007 as it responded to a spate of problems linked to contaminated food products shipped from foreign countries (2 (Also see "Delays From Import Alert Highlight Communication, Analytical Testing Issues" - Pink Sheet, 21 May, 2007.), p. 6).

His line authority, however is only over the staff in the Office of Food Protection, according to FDA.

However, no single FDA post currently has responsibility for all of the agency's food safety activities, Levi said, adding that FDA can create the post administratively, without new legislation.

No single person is solely dedicated to food issues and has line authority over all food safety functions, FDA acknowledged.

Michael Taylor, a former deputy commissioner for policy at FDA and a consultant on the report, said not having a food safety czar creates the absence of accountability.

The FDA commissioner "theoretically has authority to both manage and lead reform of the FDA food safety program," said Taylor, a health policy professor at the George Washington University. However, the commissioner also is responsible for medical product regulation, which "historically has taken priority within FDA," he added.

"The practical result of this fragmented structure and lack of full-time leadership of food safety is that no one is really in charge and realistically accountable for the success or failure of the FDA food safety program," Taylor said.

TFAH and RWJF say an FDA deputy commissioner "with line authority over all food safety programs" should be established before moving toward a longer term goal of creating a separate food agency.

Observers say the choices for FDA's top posts leave the Obama administration well positioned in case, over the longer term, the government creates a separate food agency.

Sources close to the decisions to select Margaret Hamburg as commissioner and Josh Sharfstein as principal deputy commissioner say they will not split duties along food and medical product lines (3 (Also see "Hamburg/Sharfstein Appointments Do Not Signal Split Duties At FDA" - Pink Sheet, 23 Mar, 2009.), p. 3).

However, some observers believe the administration made both choices with an eye to having a leader who could remain in charge of FDA's medical products and one who would be ready to step in to head a food agency.

Levi noted there is congressional support for food safety reform, including a proposal for a food safety agency under HHS (4 (Also see "First Course For Waxman: Fix Food Safety, Hold The Separate Agency Plan" - Pink Sheet, 16 Mar, 2009.), p. 16).

- Katie Stevenson ([email protected])

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